AstraZeneca gains EU approval for Saphnelo self-injection pen in lupus treatment

AstraZeneca gains EU approval for Saphnelo self-injection pen in lupus treatment

AstraZeneca has received European Commission approval for a new subcutaneous formulation of Saphnelo (anifrolumab), allowing adult patients with systemic lupus erythematosus (SLE) to self-administer the drug via a once-weekly pre-filled pen. The regulatory decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by data from the Phase […]

Is twice-yearly dosing the future of autoimmune care? Inside Amgen’s UPLIZNA playbook for chronic neurology

Is twice-yearly dosing the future of autoimmune care? Inside Amgen’s UPLIZNA playbook for chronic neurology

When Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration had approved UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG), the industry’s attention snapped not just to the therapy’s mechanism but to its twice-yearly maintenance schedule. For patients, this marks a seismic shift away from the exhausting cycle of daily oral immunosuppressants […]